Superphosphates, concd.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented, near-guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

24 h exposure under occlusive conditions; no scoring after 48 h

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium dihydrogenorthophosphate

EC Number:

231-764-5

EC Name:

Ammonium dihydrogenorthophosphate

Cas Number:

7722-76-1

Molecular formula:

H3N.H3O4P

IUPAC Name:

ammonium dihydrogen phosphate

Constituent 2

Reference substance name:

Monoammonium dihydrogenorthophosphate

IUPAC Name:

Monoammonium dihydrogenorthophosphate

Details on test material:

- Name of test material (as cited in study report): Monoammoniumphosphate, Härter 26 Pulver
- Analytical purity: no data

Test animals

Species:

rabbit

Strain:

Vienna White

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 80%

Duration of treatment / exposure:

24 h

Observation period:

9 days

Number of animals:

3 male and 3 female

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: No experimental data available for 24 h reading; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: No experimental data available for 24 h reading; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: No experimental data available for 24 h reading; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)

Any other information on results incl. tables

	time	animal 1	animal 2	animal 3	animal 4	animal 5	animal 6
erythema	24 h	1	1	0	0	0	1
	72 h	0	0	0	0	0	0
	9 d	0	0	0	0	0	0
edema	24 h	0	0	0	0	0	0
	72 h	0	0	0	0	0	0
	9 d	0	0	0	0	0	0

No experimental data available for 24 h reading; for calculation of mean scores, therefore the 48 h values were assumed to be the same as those at 24 h (worst case assumption).

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU